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Clinical Trials/NCT02725515
NCT02725515CompletedPhase 2

A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity

Xencor, Inc.23 sites in 1 country105 target enrollmentStarted: February 16, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
105
Locations
23
Primary Endpoint
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus Erythematosus (SLE) disease activity improvement achieved by a brief course of disease-suppressing steroid therapy

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with a diagnosis of SLE as defined by the ACR criteria
  • •Patients have a history of a (+) ANA, (+) ENA or a (+) anti-dsDNA serology documented within one year prior to randomization
  • •Investigator has assessed the patient and in their judgment, the SLE disease activity is not organ threatening
  • •Both investigator and patient agree that it is acceptable to discontinue their current immunosuppressant SLE medications and receive a brief course of IM steroid therapy
  • •If patients are on oral steroids, they must be on the equivalent of ≤15 mg/day of prednisone to enter screening, and must be able to taper to ≤10 mg/day by randomization

Exclusion Criteria

  • •History or evidence of a clinically unstable/uncontrolled disorder, condition or disease, other than SLE that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures or completion
  • •Patients who have organ threatening manifestations of SLE including active Class 3 or 4 lupus nephritis requiring induction or maintenance therapy or any other disorder for which stopping SLE therapy is contraindicated
  • •Active CNS lupus such as seizures or psychosis that in the opinion of the investigator would preclude participation
  • •Unstable hemolytic anemia or thrombocytopenia
  • •Patient is pregnant or breast feeding, or planning to become pregnant while participating in the study
  • •Use of any biologic therapy (including belimumab) within 6 months of randomization, or prior exposure to a monoclonal antibody directed to CD20 (such as rituximab) within 12 months of randomization

Arms & Interventions

Placebo

Placebo Comparator

Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions

Intervention: Placebo to match XmAb5871 (Biological)

XmAb5871

Experimental

XmAb5871 administered by IV infusion for up to a total of 16 infusions

Intervention: XmAb5871 (Biological)

Outcomes

Primary Outcomes

Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225

Time Frame: Day 225

Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225

Secondary Outcomes

  • Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169(Day 169)
  • Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients(From the date of randomization until the date of loss of Systemic Lupus Erythematosus Disease Activity Improvement, or the date of the final efficacy assessment, up to 239 days.)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (23)

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